Two monoclonal antibodies administered together, bamlanivimab and etesevimab, received emergency use authorization (EUA) for mild to moderate COVID-19 patients at risk of severe disease, the FDA said late Tuesday.
The treatment was authorized for adult and pediatric patients, including those age 65 and older with chronic medical conditions, the agency said.
They specified that the combination is not authorized for hospitalized COVID-19 patients or those who need oxygen therapy due to the disease, as it has not been studied in this population and may be associated with worse outcomes when given to patients requiring high-flow oxygen or mechanical ventilation.
“The data supporting this emergency authorization add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients,” Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
FDA cited data from a randomized trial of 1,035 non-hospitalized adults with mild to moderate COVID-19 at high risk of progressing to severe disease, where 518 received a single 2,800 mg infusion of bamlanivimab and etesevimab each, and 517 received placebo. The primary endpoint of COVID-19 hospitalization or death during 29 days of follow-up occurred in 2% of the intervention group versus 7% of those receiving placebo, with all 10 deaths among the placebo group.
However, under the EUA, the authorized dosing is 700 mg of bamlanivimab and 1,400 mg of etesevimab, as the FDA says it is expected to have similar clinical and virological effects as the 2,800 mg doses administered together.
In November, bamlanivimab monotherapy was authorized under an EUA for mild to moderate COVID-19 patients at risk of progressing to severe disease, though manufacturer Eli Lilly previewed the combination results in a press release back in October and peer-reviewed data on the two antibody treatments in the BLAZE-1 trial were published in January.
FDA noted that serious adverse events — including hypersensitivity, anaphylaxis, and infusion-site reactions — have been observed with bamlanivimab with and without co-administration of etesevimab. Other side effects of both treatments administered together include nausea, dizziness, pruritus, and rash.
Source: MedicalNewsToday.com
